- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036019
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Aibin Liang, MD,Ph.D.
- Phone Number: 0086-021-66111019
- Email: lab7182@tongji.edu.cn
Study Locations
-
-
-
Shanghai, China, 200065
- Shanghai Tongji Hospital, Tongji University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient volunteered to participate in the study, and signed the Informed Consent
- Age 18-70 years old, male or female
- Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
- r/r lymphoma patients who received prior CD19 CAR-T therapy
- At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
- No mAb treatment within 2 weeks before C-CAR066 infusion
- Adequate organ and bone marrow function
- No contraindications of apheresis
- Expected survival time > 3 months
- ECOG scores 0-1
Exclusion Criteria:
- Have a history of allergy to cellular products
- Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
- A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
- Patients with active CNS involvement
- Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
- Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
- Live vaccination within 4 weeks before apheresis
- HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
- Have a history of alcoholism, drug addiction and mental illness
- Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
- Patients with severe fludarabine or cyclophosphamide hypersensitivity
The patient has a history of other primary cancers, except for the following:
- Non-melanoma such as skin basal cell carcinoma cured by resection
- Cured carcinoma in situ such as cervical, bladder or breast cancer
- The investigators believe that there are other circumstances that are not suitable for the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C-CAR066
Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
|
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 12 weeks after C-CAR066 infusion
|
The incidence of treatment-emergent adverse events (TEAEs)
|
Up to 12 weeks after C-CAR066 infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Up to 24 months after C-CAR066 infusion
|
The percentage of subjects who achieved complete response and partial response
|
Up to 24 months after C-CAR066 infusion
|
Complete response rate (CRR)
Time Frame: Up to 24 months after C-CAR066 infusion
|
The percentage of subjects who achieved complete response
|
Up to 24 months after C-CAR066 infusion
|
Duration of response (DOR)
Time Frame: Up to 24 months after C-CAR066 infusion
|
The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion
|
Up to 24 months after C-CAR066 infusion
|
Progression free survival (PFS)
Time Frame: Up to 24 months after C-CAR066 infusion
|
The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death
|
Up to 24 months after C-CAR066 infusion
|
Overall survival (OS)
Time Frame: Up to 24 months after C-CAR066 infusion
|
Time from C-CAR066 infusion to death from any cause
|
Up to 24 months after C-CAR066 infusion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aibin Liang, MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0504-009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on B Cell Lymphoma
-
Iksuda Therapeutics Ltd.RecruitingFollicular Lymphoma | B-cell Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | B-cell Non-Hodgkin LymphomaAustralia, Canada, United States
-
Nathan DenlingerBristol-Myers SquibbRecruitingB-Cell Non-Hodgkin Lymphoma-Recurrent | Diffuse Large B-Cell Lymphoma-Recurrent | Follicular Lymphoma-Recurrent | High Grade B-Cell Lymphoma-Recurrent | Primary Mediastinal Large B-Cell Lymphoma-Recurrent | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and other conditionsUnited States
-
AstraZenecaRecruitingFollicular Lymphoma | Diffuse Large B Cell Lymphoma | High-grade B-cell Lymphoma | B-cell Non Hodgkin LymphomaKorea, Republic of, United States, Japan, Australia, Taiwan
-
Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
-
University of ChicagoMerck Sharp & Dohme LLCRecruitingLymphoma | Lymphoma, B-Cell | B Cell Lymphoma | Diffuse Large B Cell Lymphoma | High-grade B-cell LymphomaUnited States
-
Massachusetts General HospitalVarian Medical SystemsRecruitingLymphoma, B-Cell | Follicular Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Lymphoma | High-grade B-cell Lymphoma | Relapsed Cancer | Mediastinal Large B-cell LymphomaUnited States
-
Curocell Inc.RecruitingHigh-grade B-cell Lymphoma | Diffuse Large B-cell Lymphoma (DLBCL) | Primary Mediastinal Large B-Cell Lymphoma (PMBCL) | Transformed Follicular Lymphoma (TFL) | Refractory Large B-cell Lymphoma | Relapsed Large B-cell LymphomaKorea, Republic of
-
Dana-Farber Cancer InstituteBayer; AbbVieActive, not recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited States
-
Qian WenbinNot yet recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaChina
-
University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
Clinical Trials on CD20-directed CAR-T cells
-
Peking Union Medical College HospitalUnknown
-
RenJi HospitalAbelZeta Pharma Inc.RecruitingA Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy (CAR-AID)Systemic Lupus Erythematosus (SLE) | Neuromyelitis Optica Spectrum Disorders | Immune-Mediated Necrotizing Myopathy | Multiple Sclerosis-Relapsing-RemittingChina
-
Southwest Hospital, ChinaUnknownLymphoma, Large B-Cell, DiffuseChina
-
Southwest Hospital, ChinaUnknown
-
Miltenyi Biomedicine GmbHDLR German Aerospace CenterRecruiting
-
Miltenyi Biomedicine GmbHActive, not recruitingNon-Hodgkin's Lymphoma | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma | B-cell Lymphoma Refractory | B-cell Lymphoma RecurrentGermany
-
Xin WangUnknownRelapsed or Refractory B-cell LymphomasChina
-
He HuangYake Biotechnology Ltd.RecruitingRelapsed and Refractory | Lymphoid Hematological MalignanciesChina
-
Shanghai Tongji Hospital, Tongji University School...UnknownLymphoma | LeukemiaChina
-
Technische Universität DresdenGerman Cancer Research CenterRecruitingNeoplasms | Multiple Myeloma in Relapse | Multiple Myeloma, Refractory | Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Refractory Diffuse Large B-cell Lymphoma (DLBCL)Germany